A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Interventions
- Registration Number
- NCT06637423
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
The key inclusion criteria include but are not limited to the following:
-
Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder
-
Must have visible tumor by cystoscopy within 12 weeks prior to first dose
-
Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:
- Multiple tumors
- >1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
- Early recurrence (<1 year) of the initial diagnosis of low-grade disease
- Solitary tumor >3 cm
- Failure of prior intravesical treatment
-
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose
The key exclusion criteria include but are not limited to the following:
- Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
- Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
- Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sacituzumab tirumotecan Sacituzumab tirumotecan Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks Sacituzumab tirumotecan Rescue medication Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks Sacituzumab tirumotecan Supportive care measures Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicity (DLT) Up to approximately 7 weeks DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0.
Number of Participants Experiencing an Adverse Event (AE) Up to approximately 10 weeks An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE) Up to approximately 6 weeks An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC) Up to approximately 6 weeks Blood samples will be collected to determine the AUC of sac-TIMT ADC
Maximum Serum Concentration (Cmax) of sac-TMT ADC Up to approximately 6 weeks Blood samples will be collected to determine the Cmax of sac-TMT ADC
Minimum Serum Concentration (Cmin) of sac-TMT ADC Up to approximately 6 weeks Blood samples will be collected to determine the Cmin of sac-TMT ADC
Serum Apparent terminal half-life (t½) of sac-TMT ADC Up to approximately 6 weeks Blood samples will be collected to determine the t1/2 of sac-TMT ADC
Serum AUC of sac-TMT Total Antibody (TAb) Up to approximately 6 weeks Blood samples will be collected to determine the AUC of sac-TMT Tab
Serum Cmax of sac-TMT Tab Up to approximately 6 weeks Blood samples will be collected to determine the Cmax of sac-TMT Tab
Serum Cmin of sac-TMT Tab Up to approximately 6 weeks Blood samples will be collected to determine the Cmin of sac-TMT Tab
Serum t½ of sac-TMT Tab Up to approximately 6 weeks Blood samples will be collected to determine the t1/2 of sac-TMT Tab
Plasma AUC of sac-TMT payload Up to approximately 6 weeks Blood samples will be collected to determine the AUC of sac-TMT payload
Plasma Cmax of sac-TMT payload Up to approximately 6 weeks Blood samples will be collected to determine the Cmax of sac-TMT payload
Plasma Cmin of sac-TMT payload Up to approximately 6 weeks Blood samples will be collected to determine the Cmin of sac-TMT payload
Plasma t½ of sac-TMT payload Up to approximately 6 weeks Blood samples will be collected to determine the t1/2 of sac-TMT payload
Complete Response Rate (CRR) Up to approximately 6 months CRR is defined as the percentage of participants who will be absent of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable.
Duration of Complete Response (DCR) Up to approximately 24 months Duration of CR for participants who demonstrate CR is defined as the time from the first documented evidence of CR (absence of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable) until the occurrence of histologically confirmed nonmuscle invasive urothelial carcinoma (UC) by local pathology review or locally advanced or metastatic UC, or death due to any cause, whichever occurs first.
Trial Locations
- Locations (5)
CIUSSS de l'Estrie-CHUS ( Site 0002)
🇨🇦Sherbrooke, Quebec, Canada
Michael G Oefelein Clinical Trials ( Site 0053)
🇺🇸Bakersfield, California, United States
Northwestern University ( Site 0051)
🇺🇸Chicago, Illinois, United States
Hospital Universitario Virgen de la Victoria ( Site 0043)
🇪🇸Malaga, Andalucia, Spain
Hospital Universitario 12 de Octubre ( Site 0042)
🇪🇸Madrid, Spain